Kelly Davio

June 08, 2018

This week, a Delaware District court granted Boehringer Ingelheim’s (BI) motion to compel discovery in AbbVie v Boehringer Ingelheim, an ongoing litigation over adalimumab (Humira).

June 07, 2018

The question of whether to switch patients from a reference biologic to an available biosimilar has been the subject of extensive debate, especially in patients with inflammatory bowel disease (IBD), an indication in which evidence on relevant clinical outcomes after switching is limited.

June 07, 2018

During the 2018 American Society of Clinical Oncology Annual Meeting, researchers published new findings on the use of rituximab in mantle cell lymphoma (MCL) as well as the outcomes of patients who relapse early after treatment with rituximab for diffuse large B-cell lymphoma (DLBCL).

June 06, 2018

Clinical practice guidelines recommend the use of granulocyte-colony stimulating factor (G-CSF) therapies, including the long-acting pegfilgrastim (Neulasta), for the prevention of febrile neutropenia in patients receiving myelosuppressive chemotherapy. Real-world data, published in an abstract concurrent with the 2018 American Society of Clinical Oncology Annual Meeting, demonstrate the feasibility of administering pegfilgrastim via an on-body device.

June 05, 2018

Celltrion presented new research that demonstrates that a formulation of its infliximab biosimilar intended for subcutaneous administration is comparable to the intravenously administered option. The phase 1 study compared the subcutaneous formulation—which can be self-administered—with the FDA-approved intravenous formulation in patients with active Crohn disease (CD).

June 05, 2018

Research published in conjunction with the 2018 American Society of Clinical Oncology Annual Meeting presented new findings on the use granulocyte-colony stimulating factor agents in treating febrile neutropenia (FN) and in peripheral stem cell mobilization.

June 05, 2018

The FDA has approved Mylan and Biocon’s pegfilgrastim biosimilar, pegfilgrastim-jmdb. The product, the first biosimilar pegfilgrastim approved in the United States, will be sold under the brand name Fulphila.

June 04, 2018

On June 1, drug maker Apotex announced that its Apobiologix division has received approval from Health Canada for its pegfilgrastim biosimilar, Lapelga. Lapelga is the first pegfilgrastim biosimilar to be approved in a highly regulated territory.

June 04, 2018

During the 2018 American Society of Clinical Oncology's Annual Meeting, researchers presented findings on 3 biosimilar trastuzumab products: Samsung Bioepis’ SB3, Agmen’s ABP 980, and Biocad’s Herticad.

June 01, 2018

Amgen has announced that the FDA has issued a Complete Response Letter for its biosimilar trastuzumab candidate, ABP 980.